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Colorectal Cancer Screening Intervention in UWPN Clinics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00161460
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : May 13, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Cynthia Ko, University of Washington

Brief Summary:
The purpose of this study is to determine if a prototype colorectal cancer screening program with the services of a cancer prevention specialist will increase utilization of appropriate colorectal cancer screening tests.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasia Behavioral: colorectal cancer screening intervention Not Applicable

Detailed Description:

Colorectal cancer is the second leading cause of cancer death in the United States. Colorectal cancer screening is widely recommended, but generally under-utilized. Previous studies have shown that only a minority of people over the age of 50 are screened for colorectal cancer with either fecal occult blood testing or flexible sigmoidoscopy. Barriers to screening include patient and provider-related factors. An innovative program to support primary care providers in providing necessary education about colorectal cancer screening, to provide reminders when screening tests are due, and to facilitate requesting and follow-up of screening tests may help address some of these barriers to providing screening services.

In this proposal, we will develop and implement a primary care based-colorectal cancer screening program to supplement clinical services provided in a primary care practice network. This network uses an electronic medical record and has established referral patterns for gastrointestinal endoscopy services, radiology, and pathology. In the proposed screening program, we will develop a colorectal cancer screening module to supplement the existing electronic medical record. This module will enable providers to review risk factors for colorectal cancer, prior screening history, and need for future screening in one easily accessible location. The information provided by this module will be supplemented by the services of a cancer prevention specialist. This person will oversee enrollment of patients into the program, provide patient education about colorectal cancer screening, and facilitate ordering or referral for screening or follow-up tests.

Outcome measures will include utilization of screening rates, patient knowledge about screening tests, and provider acceptance of the program. If successful, this program may be useful to other large primary care practices, and may also help to improve utilization of other types of cancer prevention services.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Colorectal Cancer Screening Intervention in UWPN Clinics
Study Start Date : June 2005
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Study nurse contacts subjects who enroll in the intervention to provide detailed education about screening tests, to assess their risk for colorectal cancer, and to facilitate screening.
Behavioral: colorectal cancer screening intervention
Enrolled subjects receive tailored education from a registered nurse who also facilitates ordering and completion of screening tests

No Intervention: 2
Patients who do not enroll receive usual care from their primary care providers.

Primary Outcome Measures :
  1. Colorectal cancer screening test utilization [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Knowledge about colorectal cancer screening tests [ Time Frame: 2 months ]
  2. Cancer worry score [ Time Frame: 2 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 50 years and over, enrolled for medical care in the UWPN clinics

Exclusion Criteria:

  • Primary care physicians feel they would not benefit from colorectal cancer screening, unwilling or unable to complete study procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00161460

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United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
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Principal Investigator: Cynthia Ko, MD University of Washington
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Responsible Party: Cynthia Ko, Associate Professor, University of Washington Identifier: NCT00161460    
Other Study ID Numbers: 26840-J
1R21CA107157 ( U.S. NIH Grant/Contract )
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Keywords provided by Cynthia Ko, University of Washington:
Colorectal cancer
Mass screening
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases